A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of GBT440 Administered Orally to Patients With Sickle Cell Disease
Phase of Trial: Phase III
Latest Information Update: 05 Jul 2018
At a glance
- Drugs Voxelotor (Primary)
- Indications Sickle cell anaemia
- Focus Registrational; Therapeutic Use
- Acronyms GBT-HOPE; HOPE
- Sponsors Global Blood Therapeutics
- 27 Jun 2018 According to the Global Blood Therapeutics media release, based on the positive Part A results and ongoing regulatory discussions, GBT continues to dose Part A patients, plus approximately 100 additional patients across all three treatment arms, to gather more data. At this time, GBT does not plan additional enrollment until it completes discussions with the FDA.
- 27 Jun 2018 Primary endpoint (Change in hemoglobin (Hb) at 1500 mg and 900 mg dose of voxelotor) has been met.
- 27 Jun 2018 According to the Global Blood Therapeutics media release, plans to present results from Part A at a medical meeting later this year.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History